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Start Your New Year Right

Posted by: Ken Phelps

Published on: January 4, 2010

Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that poor oversight of manufacturing and testing subcontractors will be a concern for the FDA. This concern translates into approval delays. A completed response was received by Pharmaxis Ltd. for Aridol [Mannitol dry powder for inhalation] which stated that the application could not be approved in the present form. Deficiencies were cited at three manufacturing and testing subcontractors. The company said it will address the issues as soon as possible.

The NDA was submitted in March 2009 by Pharmaxis, an Australian company. The product is approved in many countries so it would appear that Pharmaxis was relying on past approvals — thinking that other regulatory agencies’ reviews and inspections would translate to FDA approval.

It is important to manage subcontractors to avoid the CMC issues that are plaguing Pharmaxis Ltd.. The Sponsor of an application for a new drug product cannot take for granted that the subcontractors are in compliance.

At Camargo, we have auditors and project management that carefully tracks all subcontracting and assures compliance with FDA cGMP. We recently found that an ink used in printing product identity on the dosage form was not GRAS. This was found after multiple consultants reviewed the dossier. What we have found is that using individual consultants allows items to slip between their individual experiences.

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